Evaluation of Adhering Flowable Composite With and Without Adhesive Vs Flowable in Cervical Lesions
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|ClinicalTrials.gov Identifier: NCT03859284|
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : October 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dental Restoration Failure||Other: flowable resin composite Other: self adhering flowable Other: self adhering flowable with adhesive||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical Evaluation of a Moist Bonding Self-Adhering Flowable Composite With and Without Adhesive System Versus Conventional Flowable Composite in Cervical Caries Lesions: Randomized Clinical Trial|
|Actual Study Start Date :||June 20, 2020|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||June 1, 2022|
Active Comparator: flowable resin-composite
3M flowable composite is a conventional restoration to treat anterior carious cervical lesions. considered to be the gold standard of the flowable composites.
other names: ''flowable composite ''
Other: flowable resin composite
Other Name: conventional flowable composite
Experimental: self-adhering flowable
intervention one is moist bonding self adhering flowable composite that binds to tooth without an adhesive system
Other: self adhering flowable
moist bonding self adhering flowable composite
Other Name: embrace wet bond
Experimental: self-adhering flowable with adhesive
intervention two moist bonding self adhering flowable composite that binds to tooth with the aid of adhesive system to improve the clinical performance
Other: self adhering flowable with adhesive
moist bonding self adhering flowable composite with the aid of an adhesive system.
Other Name: embrace wet bond with adhesive
- Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of the direct restoration. (FDI) criteria includes [ Time Frame: Change from the baseline at 6 months and12 months] ]
Biological properties (Postoperative hypersensitivity & tooth vitality, Recurrence of caries, erosion & abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth),Adjacent mucosa, Oral & general health).
Esthetic properties (Surface luster, Staining (surface &margin),Color match & translucency & Esthetic anatomical form).
Functional properties (Fracture or material retention, Marginal integrity, Occlusal contour &wear (quantitatively & qualitatively), Proximal anatomical form(contact point &contour), Radiographic examination(when applicable) &Patient's view
For each criteria one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory & poor).
Subscales will not be combined
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859284
|Contact: mona mounir, firstname.lastname@example.org|
|Contact: hussein gomaa, PhDemail@example.com|
|Faculty of Dentistry Cairo University||Recruiting|
|Contact: faculty of dentistry|